Hepatitis B Virus (HBV) DNA, Quantitative Real-time PCR With Reflex to HBV Genotype Plus Drug Resistance
Use
This test quantitates HBV DNA in serum or plasma with reflex to HBV genotype and drug resistance testing if ≥500 IU/mL is detected.
Special Instructions
The test utilizes a quantitative PCR method to detect HBV DNA levels. Reflex testing is performed for genotyping and drug resistance if the quantitative test result is ≥500 IU/mL. Clinicians should ensure proper sample handling and utilize the specified containers for accurate results. Prompt freezing and use of the correct tubes are crucial for preventing sample rejection.
Limitations
The assay is limited to quantifying HBV DNA within a range of 10 IU/mL to 1,000,000,000 IU/mL. Genotyping and drug resistance analysis are only conducted if viral load meets or exceeds 500 IU/mL. Certain specimen handling errors, such as use of incorrect tubes or failure to freeze samples promptly, may lead to sample rejection. The test is not FDA cleared or approved, indicating reliance on clinical judgment alongside the results.
Methodology
PCR-based (qPCR)
Biomarkers
LOINC Codes
- 42595-9
- 48398-2
- 19147-8
- 32366-7
- 54210-0
- 43279-9
- 30283-6
- 30288-5
- 56792-5
- 56791-7
- 41396-3
Result Turnaround Time
7-12 days
Related Documents
For more information, please review the documents below
Specimen
Plasma
Volume
3 mL
Minimum Volume
1.5 mL
Container
Red-top tube, gel-barrier tube, lavender-top (EDTA) tube, or PPT
Collection Instructions
Centrifuge sample within six hours of collection. Transfer the serum/plasma to a screw-top polypropylene tube and freeze.
Storage Instructions
Freeze.
Causes for Rejection
Green-top (heparin) or yellow-top (ACD) tubes used for collection; serum/plasma not frozen; PPT not centrifuged
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